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Personal Kinetigraph (Pkg) System

by Gkc Manufacturing Pty Ltd 2 variants

510(k) K140086

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

Trust

Unverified

Source FDA 510(k), synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK140086 Date22 Aug 2014ClearedStatusActive

Official records

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA product code
GYD
FDA applicant
Gkc Manufacturing Pty, Ltd.
Device class
Class II
Regulation
21 CFR Part 882.1950
Advisory committee
Neurology
FDA decision
SESE Substantially Equivalent

Related clearances

cited in the FDA summary

Clearances this device's FDA summary refers to, and clearances whose summaries refer to it: a citation, not a claim of equivalence.

Cites

Cited by

Source: 510k-lineage (choiben314), CC BY 4.0

Overview

AI-generated summary, 1 Oct 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The Personal Kinetigraph (PKG) System GKC-2000 is a Class II medical device classified as a Transducer, Tremor (product code GYD). It is designed to measure and quantify kinematic data related to movement disorders, including tremor, bradykinesia, and dyskinesia, aiding in the assessment of neurological conditions such as Parkinson’s disease. The system captures real-time motion data to evaluate symptom severity and treatment response. Its regulatory classification under 882.1950 reflects its role in diagnostic monitoring of tremor-related pathologies.

The PKG System GKC-2000 is supplied as a portable, wearable device paired with a PKG Smart Charger for battery management. It operates in non-sterile environments and is intended for single-use or reusable applications, depending on clinical protocols. The device is MRI-unsafe and must be removed prior to MRI procedures. Storage requires protection from extreme temperatures and physical damage. Authorized under FDA 510(k) clearance (K140086), it adheres to special controls for Class II devices, ensuring compliance with regulatory standards for tremor assessment technologies.

Similar devices

Other devices filed under FDA product code GYD (Transducer, Tremor).

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